How Does Medicare Cover or At Least Partly Cover Experimental Treatments?
Experimental treatments refer to medical procedures, drugs, or devices that have not yet received approval from the U.S. Food and Drug Administration (FDA) for general use. These treatments are typically available through clinical trials, which are research studies conducted to evaluate the safety and effectiveness of new medical interventions. When it comes to Medicare and experimental treatments, the coverage rules become more intricate.
Medicare Coverage for Experimental Treatments
Clinical Trials: Medicare covers the routine costs of qualifying clinical trials. Routine costs include items and services that Medicare would normally cover if they were not part of a clinical trial. This may include doctor visits, hospital stays, and diagnostic tests. Medicare also covers any complications that arise from participation in the trial. However, Medicare does not cover the costs of the experimental treatment itself or any associated investigational items and services unless they are otherwise covered outside of the trial.
Coverage with Evidence Development (CED): Under certain circumstances, Medicare may provide coverage for treatments considered experimental if they are part of a Coverage with Evidence Development (CED) study. CED allows Medicare to cover new technologies or procedures while collecting additional data on their effectiveness. This coverage is conditional and typically applies to treatments that show promise but require more evidence to support their widespread use.
Investigational Device Exemption (IDE) Studies: For medical devices, Medicare may cover the costs of care if the device is part of an Investigational Device Exemption (IDE) study approved by the FDA. The IDE allows the investigational device to be used in a clinical study to collect safety and effectiveness data. Medicare coverage in these cases includes routine costs and any necessary services to treat complications arising from the use of the device.
Expanded Access Programs: Sometimes referred to as "compassionate use" programs, these allow patients with serious or immediately life-threatening conditions to access experimental treatments outside of clinical trials. While Medicare does not typically cover the experimental treatment itself in these cases, it may cover related medical costs, such as hospital stays or necessary procedures.
Coverage Limitations
Despite the above rules, there are limitations to Medicare's coverage of experimental treatments:
Approval Process: Medicare requires that the clinical trial or study meet specific criteria and be conducted by qualified researchers. The treatment must also show potential for benefit, which is determined by Medicare administrators and advisors.
Documentation and Justification: Physicians and researchers must provide adequate documentation and justification for the treatment, including evidence of potential benefit and safety.
Cost-Sharing: Patients may still incur out-of-pocket costs for experimental treatments. While routine care might be covered, the cost of the experimental treatment itself is often not covered, leaving patients to seek other funding sources.